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PULSE: Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS
NCT01482286Phase 3
Key facts
- Status
- Terminated
- Start
- May 2012
- Primary completion
- Apr 2016
- Countries
- 1
- Sponsor
- Pennington Biomedical Research Center
- Modality
- Small Molecules
- Drugs
- metformin
- Conditions
- polycystic ovary syndrome (PCOS)
01
Overview
Phase 3, randomised, open-label trial of metformin in polycystic ovary syndrome (PCOS) (4 arms), sponsored by Pennington Biomedical Research Center. Primary endpoint: Luteinizing Hormone Pulse Frequency at Week 24. Started May 2012; status: terminated.
02
Design
4 arms- Study design
- RandomizedOpen-label
Metformin
1000 mg extended release metformin twice per day
Dietary Restriction
25% reduction in energy intake
Exercise
Aerobic training 3-4 times/week and resistance 2 times/week
Control
No treatment, continue usual regimen
03
Who it enrols
Obese women aged 20-40 with PCOS, irregular menstrual cycles, and clinical/biochemical androgen excess, excluding those with ovulatory cycles, cardiovascular disease, diabetes, or taking medications for weight control or glucose intolerance.
04
Endpoints
Primary
Luteinizing Hormone Pulse Frequency
Secondary
Glucose Disposal Rate
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